819789-RSUD ABADI SAMBOJA-KUKAR-KALTIM- 10/06/22 16:00:36

INDONESIA

GeneXpert® Dx System
Installation Qualification Report

This report provides documented evidence of the installation of this GeneXpert® Dx System.

System Information
Software Version Status
GeneXpert® Dx System 4.8 Pass
Java Runtime Environment 1.7.0_60 Pass
GX_Utils.DLL 0.8.4.0 Pass
SQL Database Microsoft SQL Server 11.00.5058 Pass
Database gx_db 3.0.7.0 Pass
Operating System Windows 7 6.1 Service Pack 1 Pass
CIT Plug-In 1 Pass

No Instruments

Available Assays
Assay Name Version Assay Type
Xpert HCV Viral Load 1 In Vitro Diagnostic
Xpert HIV-1 Viral Load 1 In Vitro Diagnostic
Xpert MTB-RIF Assay G4 5 In Vitro Diagnostic
Xpert Xpress SARS-CoV-2 2 In Vitro Diagnostic

GeneXpert® Dx System Version 4.8 Page 1 of 2

819789-RSUD ABADI SAMBOJA-KUKAR-KALTIM- 10/06/22 16:00:36
INDONESIA

GeneXpert® Dx System
Installation Qualification Report

Installation of networked instruments complies with the setup requirements specified in the GeneXpert® Dx
System Operator Manual, 'Installation' section.

Verified by Date
This IQ is acceptable if all System Information and Instrument Information are listed as 'Pass'. All instrument
modules that are listed as 'Pass' are available for use.

Acceptance: [ ] Acceptable [ ] Not Acceptable

Performed by Date

Reviewed and approved by Date

GeneXpert® Dx System Version 4.8 Page 2 of 2